This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Name: Speed Control Dial Component Used with the SmartDrive MX2+ Power Assist Device
- Part Number: MX2-3DCK, MX2-3DC
- Serial Numbers: All manufactured from August 17, 2023 to November 21, 2024
What to Do
- Stop using the SpeedControl Dial immediately.
- Switch to an alternate controller such as a wired or wearable controller.
If one of the performance issues occurs before a corrected SpeedControl Dial is received:
- Press the face of the SpeedControl Dial if continued drive or involuntary movement occurs.
- Rotate the SpeedControl Dial back to zero position and reengage power assist if power to the device is lost.
- Wait for a replacement if the device fails to start driving.
On December 20, 2024, Max Mobility/Permobil sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
- Stop using the SpeedControl Dial.
- Use another type of wired controller (SwitchControl buttons or SwitchControl with mono jack and mechanical switch) or wearable controller (compatible Apple Watch or Samsung Galaxy Watch once Wear OS app is released).
- Request replacement SpeedControl Dial units through the field action portal at: https://hub.permobil.com/smartdrive-scd-voluntary-field-action
- Enter the portal and:
- Enter your contact information
- Select if you are a dealer or end user
- Acknowledge you have read and understood the Urgent Medical Device Correction letter.
- Contact Max Mobility/Permobil technical support team at 800-736-0925 at any time for assistance.
Reason for Recall
Max Mobility/Permobil is recalling the SpeedControl Dial component used with the SmartDrive MX2+ Power Assist Device due to a circuit board issue that may cause the motor to be unresponsive to the user. Specifically, the device may continue to drive, move on its own without user input, lose power, or fail to start driving.
The use of affected product may cause serious adverse health consequences for users and bystanders, including skin irritation, minor cuts, bruises, muscle or ligament strain or tear, bone fractures, concussion, and death.
There have been 13 reported injuries. There have been no reports of death.
Device Use
The Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial is used with the SmartDrive MX2+ Wheelchair Power Assist component. The MX2+ is attached to a mechanical wheelchair and provides motorized assistance (power assist) to move the wheels when the user pushes on the chair’s hand rails.
